NCT06533540

Safety Study of TPX-121 on Nasolabial Folds

A Single-center, Single Group, Dose Escalation, Phase 1 Clinical Trial to Investigate the Safety of TPX-121 in Subjects With Moderate-to-Extreme Nasolabial Folds

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Tego Science, Inc. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

Nasolabial folds augmentation is possible through dermal filler and botulinum toxin, however, safety issues are existed as well as efficacy. Therefore, there is a need for a safer procedure for nasolabial folds correction. This study (Project No. TPX-121) assesses the safety of allogeneic fibroblasts (TPX-115) on nasolabial folds. The safety endpoint is dose-limiting toxicity (DLT). In addition, exploratory endpoints are the improvement of nasolabial folds in Wrinkle Severity Rating Scale (WSRS) at week 4 and 12, change in WSRS and Wrinkle Severity Scale (WSS) at week 4 and 12, and overall appearance improvement rate in Global Aesthetic Improvement Scale (GAIS) at week 4 and 12.

Conditions

• Nasolabial Fold, Hypoplastic

Interventions

Type	Name	Description
BIOLOGICAL	TPX-115(allogeneic fibroblasts)	Intradermal injection of TPX-115(allogeneic fibroblasts)

Timeline

• Start date: 2024-12-11
• Primary completion: 2026-03-01
• Completion: 2026-12-01
• First posted: 2024-08-01
• Last updated: 2025-07-22

Locations

1 site across 1 country: South Korea